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| Name | Class |
|---|---|
| Infectious Diseases Clinical Research Program | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The purpose of this research is to determine the effectiveness of the novel H1Nl influenza (inactivated/killed formulation) vaccine among both HIV-infected and HIV-uninfected persons. The administration of the H1Nl vaccination is not part of the study's procedures, but is being given as part of routine care.
The investigators study is being conducted to evaluate and compare the seroresponses of the novel H1N1 vaccination among HIV positive and negative persons receiving the novel H1N1 vaccination as part of routine clinical care, with secondary objectives examining the impact of prior seasonal vaccinations on subsequent seroresponse to the novel H1N1 vaccination, determining potential reactions (local or systemic) to this new vaccine among patients, and assessing for potential immunologic/virologic changes (in CD4/HIV RNA levels) after H1N1 vaccination among HIV patients. Finally, the investigators will collect data on influenza-like illnesses (ILI) and H1N1 events during the study follow-up period and influenza isolates causing ILI events will be genetically characterized.
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| Measure | Description | Time Frame |
|---|---|---|
| To compare the immunogenicity via anti-hemagglutinin responses following H1N1 vaccination between HIV positive and negative persons. | interim = 2 months; 6 month f/u = 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the immunogenicity via HAI titer levels, microneutralization seroresponses and titer levels, and cellular responses following H1N1 vaccination between HIV positive and negative persons. | 1 year | |
| Among those undergoing vaccination with the seasonal influenza vaccine during the current influenza season, to compare the presence of a positive seroresponse between HIV positive and negative persons |
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Inclusion Criteria:
Exclusion Criteria:
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Males and females of all races and all military beneficiaries including active duty enlisted and officers (from all branches of service), retirees, and their dependents presenting for H1N1 vaccination as part of routine clinical care will be eligible for participation. Both HIV-positive and negative persons can participate. Since most of our HIV patients are 18-50 years of age, and seroresponse varies by age, we will enroll persons between the ages of 18-50 years.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States | ||
| Walter Reed National Military Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21148532 | Derived | Crum-Cianflone NF, Eberly LE, Duplessis C, Maguire J, Ganesan A, Faix D, Defang G, Bai Y, Iverson E, Lalani T, Whitman T, Blair PJ, Brandt C, Macalino G, Burgess T. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in an immunocompromised population: a prospective study comparing HIV-infected adults with HIV-uninfected adults. Clin Infect Dis. 2011 Jan 1;52(1):138-46. doi: 10.1093/cid/ciq019. Epub 2010 Dec 7. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Blood samples will be collected for immunologic studies including antibody titers and cellular responses. Viral isolates will be obtained and characterized among ILI cases during study participation. Blood for CD4/HIV RNA levels will also be obtained among HIV patients to determine the impact of the vaccine on these counts.
| 1 year |
| To evaluate the effect of pre-existing anti-influenza immunity and recent history of seasonal influenza vaccination on seroresponses to the H1N1 influenza vaccine among both HIV positive and negative persons. | 1 year |
| To compare the durability of the H1N1 immunologic responses at 6 months post-vaccination between HIV-infected and uninfected persons. | 1 year |
| To evaluate the number of ILIs and documented influenza cases among HIV-infected and uninfected persons after initial vaccination, and to genetically characterize the influenza strains causing ILI events in our study cohort. | 1 year |
| To evaluate the impact of CD4 counts/percentages, HIV RNA levels, and HAART use on the immunologic responses to H1N1 vaccination in HIV positive subjects. | 1 year |
| To evaluate the impact of the H1N1 vaccine on CD4 counts/percentages and HIV RNA levels in HIV positive subjects. | 2 months |
| To evaluate potential adverse reactions of the H1N1 vaccine in HIV positive versus negative subjects. | 2 months |
| Bethesda |
| Maryland |
| 20814 |
| United States |
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708 | United States |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |